MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK SHOULDER HUMERAL HEAD GLOBAL

Catalog Number UNK SHOULDER HUMERAL HEAD GLOB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Damage to Ligament(s) (1952); Pain (1994); Loss of Range of Motion (2032); Fibrosis (3167); Joint Laxity (4526); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The literature article titled, "revision of failed resurfacing hemiarthroplasty: midterm results, survival, and group comparison" written by pieter c.Geervliet, md, mike houtveen, md, inger n.Sierevelt, md, cornelis p.J.Visser, md, phd, and arthur van noort, md, phd published by orthopedics 2019 was reviewed.The article's purpose was to report the clinical functional outcomes of revision from uncemented global cap resurfacing prosthesis (depuy).Data was compiled from 36 women and 12 men who received global cap resurfacing hemiarthroplasty between january 2007 and december 2009.Eleven of these patients required revision.Article reports the caps were uncemented and cement manufacturer is not identified for revision implants.The global caps resurfacing were revised to global ap (tsa), delta xtend (rsa) or to another non-depuy shoulder arthroplasty.No adverse events are noted post revision.Depuy product: global cap humeral head.Reasons for revision of global cap (qty 11 total revisions): pain.Glenoid erosion.Loss of function (related to range of motion).Cuff arthropathy.Subluxations.Arthrofibrosis.Infection.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: UNK SHOULDER HUMERAL HEAD GLOBAL
• Type of Device: SHOULDER HUMERAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11183181
• MDR Text Key: 227747202
• Report Number: 1818910-2021-01322
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL HEAD GLOB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention